In the medical device industry, we are hypersensitive to complaints. Here, we examine complaints from a business satisfaction perspective, rather than the FDA definition, and discuss how to evaluate your customer base.
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10x for Engineers (10x for Design and Manufacturing), held earlier this month in San Diego, offered prime networking and educational opportunities for MDO's chief editor and other attendees.
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We needed to find out — in the Case For Quality Program in particular — how to get that enforcement fear out of the equation, so we could avoid the front-room/back-room concept and drive improvement.
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The American Burn Association reported approximately 486,000 fire or burn injuries were seen at emergency departments between 2011 and 2015. AVITA Medical has developed their ReCell skin regeneration platform (currently under FDA PMA review) to improve outcomes for burn victims.
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Existing electrophysiology systems don’t have the fidelity, or noise floors in the hardware and software, to allow doctors to see subtle abnormalities. Doctors believe the ability to see these subtle abnormalities may enable them to provide better, more accurate treatment for arrhythmia.
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He sat there in the room, looked the FDA reviewers in the eye, and told them there were 10 people who died at his site during the trial, and if he had been allowed to use the data from the new diagnostic, he could have saved at least five of them.
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